DERMACLEANSE ACNE SPOT TREATMENT- salicylic acid gel

Dermacleanse Acne Spot Treatment by

Drug Labeling and Warnings

Dermacleanse Acne Spot Treatment by is a Otc medication manufactured, distributed, or labeled by ZENMED Raging Creations Ltd., Sun Deep Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

DRUG FACTS:

ACTIVE INGREDIENT

SALICYLIC ACID 2.0%

PURPOSE

ACNE TREATMENT GEL.

USE

FOR THE TREATMENT OF ACNE. REDUCES SEVERITY OF ACNE BLEMISHES. ALLOWS SKIN TO HEAL. HELPS PREVENT NEW ACNE BLEMISHES FROM FORMING.

WARNINGS

FOR EXTERNAL USE ONLY. USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR. ASK A DOCTOR OR PHARMACIST BEFORE USE ON CHILDREN. IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH CARE PROFESSIONAL BEFORE USE.

KEEP OUT OF REACH OF CHILDREN.

DIRECTIONS

CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING MEDICATION. COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER ONCE DAILY BEFORE BED. BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO OR THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.

OTHER INFORMATION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

WATER, ALCOHOL (ETHANOL), GLYCERIN, HAMAMELIS VIRGINIANA (WITCH HAZEL) WATER (AND) ALCOHOL, HYDROXYETHYLCELLULOSE, GLYCERIN (AND) SPIRAEA ULMARIA EXTRACT, ZINC SULFATE, AND GLYCOLIC ACID.

QUESTIONS OR COMMENTS?

CALL: 1-888-749-4998
VISIT: ZENMED.COM
EMAIL: INFO@ZENMED.COM

PRINCIPAL DISPLAY PANEL - 30 ml Bottle Label

DERMACLEANSE™
Acne Spot Treatment Gel

Maximum Strength to
Fight Acne Fast &
Prevent Skin Damage

Pore Clearing Formula
with Meadowsweet
& Glycolic Acid

VEGAN,
PLANT-BASED

CRUELTY-FREE
CERTIFIED

30 ml | 1 oz

ZENMED
Reconstructive Skincare

24m

INGREDIENTS AND APPEARANCE

DERMACLEANSE ACNE SPOT TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 83313-0062
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.02 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
GLYCERIN (UNII: PDC6A3C0OX)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
ZINC SULFATE, UNSPECIFIED FORM (UNII: 89DS0H96TB)
GLYCOLIC ACID (UNII: 0WT12SX38S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 83313-0062-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph drug	M006	09/01/2025

Labeler - ZENMED Raging Creations Ltd. (203762150)

Establishment
Name	Address	ID/FEI	Business Operations
Sun Deep Inc.		189788201	MANUFACTURE(83313-0062)